title: Outcome of protease inhibitor substitution with nevirapine in HIV-1 infected children.
abstract: BACKGROUND
  Protease inhibitors (PIs) have been associated with metabolic complications. There is a trend to switch to simpler therapy to improve these disturbances. We report a case-series describing the effects in metabolic abnormalities in seven HIV-infected children, previously treated with protease inhibitor (PI) after switching to nevirapine.
  
  
  METHODS
  Seven children with stable PI-containing regimen and a long lasting HIV-1 RNA < 50 copies/ml were switched to nevirapine. All patients were naïve to non nucleoside reverse transcriptase inhibitor. PIs were switched to nevirapine. Preentry nucleoside reverse transcriptase inhibitors were maintained. The substitution of PIs with nevirapine was made when the patient showed hyperlipidemia or lipodystrophy or the physician and/or the patient's willingness to simplify. Clinical, laboratory data and anthropometric parameters were assessed every 3 months. Dual-energy X-Ray absorptiometry scans (DXA) was performed at baseline and at 12 months.
  
  
  RESULTS
  Seven HIV-infected children were enrolled. Median age: 130 months (99,177). Median baseline CD4%: 32%. All had HIV-1 RNA < 50 copies/ml. Median length of preentry PI-therapy was 47 months (28, 91). Median age at the beginning of nevirapine was 120 months (99,177). Median decrease in cholesterol in 7.2 mmol/L was observed (P = 0.09), from baseline to 12 months. HDL-cholesterol increased in 5.1 mmol/L (P = 0.03) throughout the study period. No significant changes were observed in DXA with regard to body fat, but changes in total body bone mineral content and lean body content were significant. CD4% remained stable. All patients but one maintained viral load < 50 copies/ml at 12 months. The patient with virologic failure referred bad adherence. Children referred to take medication more easily.
  
  
  CONCLUSIONS
  PI substitution with nevirapine improved lipid profile in our patients, although this strategy did not show significant changes in body fat or lipodystrophy.
authors.affiliation: Division of Immunodefiencies, Hospital 12 de Octubre, Madrid, Spain. maribelgt@hotmail.com
authors.forename: M Isabel
authors.initials: MI
authors.lastname: Gonzalez-Tome
authors.forename: Jose Tomas Ramos
authors.initials: JT
authors.lastname: Amador
authors.forename: M Jose Mellado
authors.initials: MJ
authors.lastname: Peña
authors.forename: M Luisa Navarro
authors.initials: ML
authors.lastname: Gomez
authors.forename: Pablo Rojo
authors.initials: PR
authors.lastname: Conejo
authors.forename: Pablo Martin
authors.initials: PM
authors.lastname: Fontelos
mesh_terms: D015502:Absorptiometry, Photon; D000273:Adipose Tissue / Q000000981:diagnostic imaging / Q000187:drug effects; D000293:Adolescent; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D018791:CD4 Lymphocyte Count; D002648:Child; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000302:isolation & purification; D006801:Humans; D006949:Hyperlipidemias / Q000139:chemically induced; D008060:Lipodystrophy / Q000139:chemically induced; D008297:Male; D019829:Nevirapine / Q000627:therapeutic use*; D011480:Protease Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use*; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D011480:Protease Inhibitors; D018894:Reverse Transcriptase Inhibitors; D019829:Nevirapine